Kornimate/medical-research-clean huggingface dataset:
here's the buzz: evaluating pediatric post op pain and nausea following tonsillectomy surgery

Conditions: Tonsillectomy

Summary: tonsillectomy is one of the most common surgeries performed in the united states, with over half a million performed annually in children younger than 15 years of age. postoperative pain is one of the most common clinical problems and may lead to poor intake, dehydration, and weight loss. management of postoperative pain is often challenging and results in additional medical costs due to unplanned emergency room visits. opioids such as codeine are commonly prescribed for pain control, however in 2013 the food \& drug administration issued a black box warning for the use of codeine in post-tonsillectomy pediatric patients. the american academy of otolaryngology-head and neck surgery recommends the use of acetaminophen and ibuprofen to successfully manage postoperative pain. with an extended recovery period, often longer than 7 days, alternative measures to reduce postoperative pain are needed. honey has been proven to possess antibacterial and anti-inflammatory properties. this intervention will evaluate the effect of tylenol, ibuprofen with honey on children's postoperative pain and nausea following tonsillectomy surgery.

this is a randomized intervention study where 100 pediatric tonsillectomy patients will received standard of care treatment for post-operative pain and randomized by their physician's standing orders on whether or not they include honey for pain management plus the standard of care alternating acetaminophen or motrin dose (50 patients in the control group and 50 patients in the intervention group). patients/ families will be consented for the study during their clinic appointment, by the provider and/ or registered nurse (rn) after surgical intervention has been determined as the plan of care or day of surgery if the consent is not present on the emr by the provider and/ or holding room rns. they will be given a pain catastrophizing scale questionnaire to complete. patient/ family will be instructed in the use of the medication, pain scale and nausea scale diary by the holding room rns and again with the pacu rns as they enter they first values before discharge to home. patients admitted to an inpatient unit are excluded from the study. the family will be called on post-op day 1 and day 4 to answer any questions concerning completing the diary. on day 5, an image of the diary will be emailed by the family to the pacu for uploading into the secure redcap database. control group families/ patients may call the physician's office postoperatively for pain support and a dose honey may be suggested for post-operative pain. these patients will be grouped into a separately and additional control patients will be enrolled until 50 control patients is achieved.

Eligibility criteria:
inclusion criteria: * english speaking * children ages 5-17 years exclusion criteria: * any child with a genetic syndrome or developmental disability * allergies to honey * non-english speaking families

Keywords: honey pediatrics post-operative pain nausea tonsillectomy complimentary and alternative medicine
total knee replacement with the rocc knee

Conditions: Osteoarthritis; Rheumatoid Arthritis

Summary: the purpose of this study was to assess the results of a total knee prosthesis specifically intended to enhance functional performance , especially in terms of physical and sports activity.

clinical and radiographic results , complications, early post-operative and late functional outcome and survivorship were studied in a continuous prospective series of 500 patients ( 602 knees) managed using the rocc knee ( biomet inc - warsaw- ind, usa). a minimum follow-up of 5 years was required.

Eligibility criteria:
inclusion criteria: * all patients receiving a total knee exclusion criteria: * patients with severe psychiatric, neurologic, cardiologic or locomotor pathology occuring after the total knee replacement

Keywords: knee prosthesis total knee replacement total knee arthroplasty prospective study therapeutic level iv
a study of laropiprant (mk-0524) in participants with moderate to severe erythematotelangiectatic rosacea (mk-0524-155)

Conditions: Rosacea

Summary: this study will assess the effect of mk-0524 relative to placebo, on signs and symptoms of rosacea and to determine the safety and tolerability profile of mk-0524 in participants with rosacea.


Eligibility criteria:
inclusion criteria: * moderate to severe erythematotelangiectatic rosacea with moderate to severe erythema of facial lesion * generally healthy excluding rosacea * presence of telangiectasia * five or less facial inflammatory lesions * able to restrict diet in order to avoid foods/drinks (including alcohol) that are known to exacerbate the signs/symptoms of rosacea * females of childbearing potential must have negative serum pregnancy test and agree to use one form of contraception exclusion criteria: * diagnosis of skin disorders, including psoriasis, acne vulgaris, perioral dermatitis or atopic dermatitis that would interfere with the clinical evaluations of rosacea * using and unable to discontinue use of phosphodiesterase (pde) 4 inhibitors, theophylline, niacin greater than 500 mg/day * known or suspected excessive alcohol intake * sensitivity to tetracyclines * ocular rosacea and/or blepharitis/meibomianitis * pregnant or breastfeeding * perimenopausal and has symptoms that cause flushing that may affect rosacea * initiated hormonal method of birth contraception within 4 months of baseline, discontinues use during the course of the study, or changes hormonal method within 4 months * active mycobacterial infection of any species within 3 years * history of mycobacterium tuberculosis infection * history of recurrent bacterial infection * congenital or acquired immunodeficiency common variable immunodeficiency (cvid), hepatitis b surface antigen positive or hepatitis b core antibody positive * human immunodeficiency virus (hiv) infection * positive for hepatitis c antibodies * malignancy or has had a history of malignancy greater than 3 years prior * will continue to use any of the following treatments during the study: systemic retinoids, therapeutic vitamin a supplements of greater than 10,000 units/day, systemic steroids, systemic antibiotics known to have an impact on the severity of facial rosacea, systemic treatment for acne, topical steroids, topical retinoids, topical acne treatments including prescription and over-the-counter (otc) preparations, topical anti-inflammatory agents, topical antibiotics, topical imidazole antimycotics, cryodestruction or chemodestruction, dermabrasion, photodynamic therapy, acne surgery, intralesional steroids, x-ray therapy, pulse-dye laser, intense pulse light, astringents, abrasives, benzoyl peroxide products, sulfur containing washes, eye washes, beta blockers, vasodilators, vasoconstrictors and/or chronic use (\>14 days) of topical or systemic anti-inflammatory agents
efficacy and safety of duloxetine

Conditions: Urinary Stress Incontinence

Summary: the purpose of this study is to monitor the long term safety and efficacy of duloxetine in the treatment of severe pure genuine stress incontinence.


Eligibility criteria:
inclusion criteria: * female out patients. * have a diagnosis of pure genuine stress incontinence on urodynamic study performed within 6 months prior to study entry. exclusion criteria: * use of monoamine oxidase inhibitors within 14 days prior to study entry or at any time during the study. * suffer from severe constipation.
phase ii study assessing safety and efficacy of apl-2 in glomerulopathies

Conditions: IgA Nephropathy; Lupus Nephritis; Membranous Nephropathy; C3 Glomerulonephritis; Dense Deposit Disease

Summary: this is a phase ii trial assessing the safety and preliminary efficacy of daily apl-2 subcutaneous infusion administered for 16 weeks with a 6 month safety follow up, in patients with glomerulopathies


Eligibility criteria:
inclusion criteria: * patients of at least 18 years of age at screening (16 years of age for c3g), able to provide written informed consent, and able to understand and comply with all scheduled procedures and other requirements of the study by the opinion of principal investigator (pi) * patients must have a diagnosis of igan, ln, primary mn, or c3g confirmed by renal biopsy and required measurements performed prior to study participation * igan: prior biopsy results for c3 and c4d staining should be made available * ln: diagnostic biopsy showing proliferative focal, diffuse, or membranous lesions (class iii, iv or v, respectively) by renal biopsy. subject should have either a biopsy in the last 6 months, or evidence of disease activity (nephritic changes on urinalysis or nephrotic changes) * primary mn: pla2r positive titer plus nephrotic range proteinuria (defined as upcr \>2350 mg/g) * c3g plus one of the following: low serum c3 level or historical renal biopsy within the last 3 years * have proteinuria \>750 mg/g (calculated by upcr on 24 hour urine collection) collected during the first screening visit (visit 3a). * egfr≥30ml/min/1.73 m2 calculated by ckd-epi creatinine equation at screening visit 3a and currently not on dialysis * must have stable or worsening renal disease, on stable and optimized treatment, in the opinion of the pi, for at least 2 months prior to the first dose of apl-2 (visit 4); treatments may include, but are not limited to, immunosuppressive agents, anti-hypertensives and/or anti-proteinurics. * willing to receive vaccinations against neisseria meningitidis at least 2 weeks prior to dosing on day 1 with a booster on day 56 (for both vaccinations) and pneumococcal and hib vaccines at least 2 weeks prior to dosing on day 1. exclusion criteria: * absolute neutrophil count \<1000 cells/mm3 at screening visits 3a and 3b * alt or ast \>3.0 x the upper limit of normal at screening visits 3a and 3b * previous treatment with apl-2 * history of solid organ transplant * diagnosis of human immunodeficiency virus (hiv), hepatitis b, or hepatitis c infection, or positive serology at screening visits 3a and 3b (previous hbv or hcv diagnosis cleared by treatment is allowed) * renal disease secondary to another condition (e.g. infection, malignancy, monoclonal gammopathy, or a medication) * presence or suspicion of active bacterial or viral infection or severe recurrent bacterial infections * participation in any other investigational drug trial or exposure to other investigational agent, device, or procedure within 30 days prior to screening period * unwillingness to receive or intolerant of sc infusions of study medication or known allergy to ingredients in apl-2.
the infuse trial - intervening with platelet transfusions in sepsis

Conditions: Sepsis; Thrombocytopenia

Summary: sepsis is life-threatening and dysregulated response to infection that results in endothelial activation and dysfunction that leads to systemic microvascular leak and multiple-organ failure. this study will identify patients that have sepsis with thrombocytopenia and randomize them to receive a unit of platelets or an equivalent volume of saline.

sepsis is life-threatening and dysregulated response to infection that results in endothelial activation and dysfunction that leads to systemic microvascular leak and multiple-organ failure. emerging evidence indicates that platelets occupy a central role in maintaining the balance between vascular health and the response to environmental changes and vascular injury. platelets are essential for vascular development and required for normal endothelial integrity. platelets also function at the interface between thrombosis and inflammation. this study will identify patients that have sepsis with thrombocytopenia and randomize them to receive a unit of platelets or an equivalent volume of saline. our overall hypotheis is that normal platelet function is required to maintain vascular integrity and can be at least partially restored over the first 24 hours by platelet transfusion in septic patients with thrombocytopenia.

Eligibility criteria:
inclusion criteria * provision of informed consent prior to any study specific procedures * female and/or male, age \>18 years * diagnosis of sepsis based on the third international consensus definitions for sepsis and septic shock * platelet count ≤ 50,000/μl exclusion criteria * active major bleeding requiring blood transfusion * other causes of thrombocytopenia such as idiopathic thrombocytopenic purpura, high clinical suspicion for heparin-induced thrombocytopenia (or other form of consumptive coagulopathy).
ivig efficacy study to treat cutaneous lupus erythematosus

Conditions: Cutaneous Lupus Erythematosus

Summary: the purpose of this research study is to show that non-steroidal treatment with intravenous immunoglobulin (ivig) can replace current systemic immunosuppressive therapy in cutaneous lupus erythematosis (cle) patients.

the ultimate goal of this pilot project is to generate proof-of-concept data showing that treatment with intravenous immunoglobulin (ivig) can replace current systemic immunosuppressive therapy in cutaneous lupus erythematosis (cle) patients. this project has relevant clinical implications due to the severe side effects of and lack of response to current therapies. from the review of literature, it can be postulated that: 1. the beneficial effects of ivig for patients with cle should be prompt, with marked improvement within a few weeks; 2. clinical improvement should last several weeks after the last infusion; and 3. remission may be prolonged by maintenance ivig therapy. although this is only a non-controlled study, the investigator expects that ivig will improve cle, including those resistant to standard treatments. it is anticipated that treatment with ivig will facilitate healing of extensive cutaneous lesions and achieve rapid remission. maintenance therapy with repeated monthly pulses of ivig is expected to keep the disease in remission during the treatment-free follow up observational period. the results will provide the basis a multicenter randomized controlled study to identify which cle subsets will benefit the most and which protocol will provide the optimal clinical outcome.

Eligibility criteria:
inclusion criteria: * evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial. * subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. * be at least 18 years of age at time of informed consent. * have had a diagnosis of cle * currently has active cle (any subtype) established by standard clinical and histo- and immunopathologic criteria * falls into one of the two following cohorts: * cohort 1 - has received a standard systemic therapy without a therapeutic response for a minimum of one month * cohort 2 - has not received any systemic treatment exclusion criteria: * subject is not over 18 years of age. * subject cannot understand or follow directions. * subject is a female of child-bearing potential and unwilling to use a form of highly effective birth control. * subject is pregnant, planning to get pregnant, or breast feeding. * subject has a known history of immunoglobulin a (iga) deficiency.

Keywords: skin, lupus, intravenous immunoglobulin, ivig
changes in thoracolumbar fascia stiffness and pain parameters in young patients with chronic low back pain

Conditions: Pain; Back Pain; Fascia

Summary: this study aims to investigate the biomechanical parameters of thoracolumbar fascia (tlf) and pain-related properties including pain intensity, pressure pain threshold (ppt) and pain sensitivity in young adults with non-specific chronic low back pain (lbp), both those experiencing chronic low back pain (lbp) and without lbp.

non-specific low back pain has become a serious public health problem in latest years. the prevalence of low back pain is reported to be 84% in lifetime (1). recently, an increasing number of studies have reported that fascia, due to its rich nociceptive innervations, may play a role in chronic pain, especially in some non-specific low back pain conditions . this study will conducted with a total of 50 participant, including those with chronic lower back pain in the experimental group and the control group. both groups underwent assessments related to pain properties. specifically, the numerical pain scale(nms) will be used to assess subjective pain intensity(4), the digital algometer for assessing pressure pain treshold(5), the pain sensitivity scale(pss) pain sensitivity(6) and the myotonometer myotonpro biomechanical parameters, including stiffness(s), elasticity(d) and tonus (f) of the tfl at the level of lumbal 1,3 vertebrae(l1,l3) and under 12th costa (7-10). spss 23.0 will be used for statistical analysis. p\<0.05 is considered statistically significant.

Eligibility criteria:
inclusion criteria: * chronic back pain participants more than 3 months exclusion criteria: * those with orthopaedic, neurological and systemic diseases will be excluded from the study.

Keywords: non-spesific back pain thoracolumbar fascia stiffness pain thresold
comparison between bronchoscopy and real- time ultrasound guided percutaneous tracheostomy

Conditions: Tracheostomy Complications

Summary: trial is a randomized study to compare between ultrasound guided percutaneous tracheostomy and bronchoscopy guided percutaneous tracheostomy.

trial is a randomized study to compare between ultrasound guided percutaneous tracheostomy and bronchoscopy guided percutaneous tracheostomy. patients will be randomly assigned to be submitted to evaluate safety, complication rates, easy to perform , clinical outcomes and effectivity.

Eligibility criteria:
inclusion criteria: * all intubated and mechanically ventilated patients indicated for a tracheostomy exclusion criteria: * patients with tracheal or neck abnormalities, soft tissue infection in the neck, neck surgery history, oxygenation problems , coagulation disorders or coagulation parameter changes and those requiring urgent or surgery patients unable to provide informed consent.

Keywords: tracheostomy complications ultrasound bronchoscopy
measuring the spectrum of tissues during endoscopy

Conditions: Colon Carcinoma; Colonic Polyps; Intestinal Polyps

Summary: lesions, polyps and other abnormalities in the gastrointestinal (gi) tract have a different composition compared to the normal mucose. the investigators plan to gather spectroscopic information from these features. characterizing their unique spectrums, may help to enhance the detection and identification of these objects during endoscopy.


Eligibility criteria:
inclusion criteria: * adult, independent patients who come to sheba hospital's gastro-intestinal clinic for endoscopy and are willing to sign an informed consent exclusion criteria: * none
an international non-interventional cohort study to evaluate the safety of treatment with insulin detemir in pregnant women with diabetes mellitus. diabetes pregnancy registry

Conditions: Diabetes Mellitus; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Summary: this study is conducted in europe and asia. the purpose of the study (diabetes pregnancy registry) is to evaluate the safety of treatment with insulin detemir in pregnant women with diabetes mellitus.


Eligibility criteria:
inclusion criteria: - informed consent obtained before any data collection - woman with a positive pregnancy test - diabetes mellitus type 1 or 2, diagnosed prior to conception - currently treated with levemir® or other injectable antidiabetic treatment(s) - unchanged basal insulin or other injectable antidiabetic treatment product (for those not treated with basal insulin) 4 weeks prior to and following conception exclusion criteria: - women who have been pregnant for more than 16 weeks at baseline visit will be excluded from the study
maintenance capecitabine plus best supportive care versus best supportive care for metastatic nasopharyngeal carcinoma

Conditions: Nasopharyngeal Carcinoma

Summary: this multicenter, randomised, phase 3 study is to evaluate the survival benefit of maintenance capecitabine plus best supportive care versus best supportive care for metastatic nasopharyngeal carcinoma patients after disease controlled with tpc palliative chemotherapy.

firstly diagnosed metastatic nasopharyngeal carcinoma patients will receive 4-6 cycles of palliative chemotherapy with taxol,cisplatin and capecitabine. after disease controlled, they will be randomly assigned to maintenance capecitabine plus best supportive care(bsc) or bsc alone. the primary end point is progression-free survival, the secondary end points are overall survival, duration of response, objective response rate, adverse effects and quality of life.

Eligibility criteria:
inclusion criteria: * firstly diagnosed metastatic nasopharyngeal carcinoma patients * disease controlled after 4-6 cycles of palliative chemotherapy with taxol,cisplatin and capecitabine * eastern cooperative oncology group (ecog) 0-2 * life expectation at least 12 weeks * no systemic chemotherapy within 6 months, except for induction chemotherapy or concurrent chemotherapy * with at least one measurable lesion * enough blood test * signed informed consent exclusion criteria: * sever heart disease * hiv infection * sever infection * brain metastasis, except received radical therapy 6 months ago and stable in 4 weeks * allogeneic organ transplantation * malignancy other than nasopharyngeal carcinoma, except:cervical carcinoma in situ, cured basal cell carcinoma,bladder cancer of ta,tis or t1, or any cured cancer for at least 3 years * pregnancy or breast feeding * difficulty in swallowing * received other test drugs

Keywords: nasopharyngeal carcinoma metastasis capecitabine